Trial Outcomes & Findings for Lurasidone Pediatric Bipolar Study (NCT NCT02046369)
NCT ID: NCT02046369
Last Updated: 2017-12-20
Results Overview
CDRS-R total score: changes from baseline over time - mixed model for repeated measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures. The CDRS-R total score ranges from 17-113. In general, higher values of CDRS-R total score represent greater severity of illness. The primary efficacy endpoint will be assessed between the placebo and treatment group.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
350 participants
Primary outcome timeframe
baseline, Week 6
Results posted on
2017-12-20
Participant Flow
Participant milestones
| Measure |
Luradisone
Luradisone 20- 80 mg administered once daily
Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily
|
Placebo
Placebo administered once daily
Placebo: Placebo Comparator once daily
|
|---|---|---|
|
Overall Study
STARTED
|
176
|
174
|
|
Overall Study
COMPLETED
|
162
|
156
|
|
Overall Study
NOT COMPLETED
|
14
|
18
|
Reasons for withdrawal
| Measure |
Luradisone
Luradisone 20- 80 mg administered once daily
Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily
|
Placebo
Placebo administered once daily
Placebo: Placebo Comparator once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Lack of Efficacy
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
|
Overall Study
never received study drug
|
0
|
1
|
|
Overall Study
non compliance
|
1
|
0
|
Baseline Characteristics
Lurasidone Pediatric Bipolar Study
Baseline characteristics by cohort
| Measure |
Luradisone
n=175 Participants
Luradisone 20- 80 mg administered once daily
Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily
|
Placebo
n=172 Participants
Placebo administered once daily
Placebo: Placebo Comparator once daily
|
Total
n=347 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
175 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
347 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
14.2 years
STANDARD_DEVIATION 2.18 • n=5 Participants
|
14.3 years
STANDARD_DEVIATION 2.01 • n=7 Participants
|
14.2 years
STANDARD_DEVIATION 2.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
175 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
347 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
135 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
260 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Colombia
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
75 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Region of Enrollment
Philippines
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Psychiatric History
|
12.44 years
STANDARD_DEVIATION 2.790 • n=5 Participants
|
12.17 years
STANDARD_DEVIATION 2.680 • n=7 Participants
|
12.30 years
STANDARD_DEVIATION 2.735 • n=5 Participants
|
|
Bipolar I disorder history
Without rapid cycling (0-3 cycles past 12 months
|
149 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
296 Participants
n=5 Participants
|
|
Bipolar I disorder history
Without rapid cycling(4-7 cycles past 12 months
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Bipolar I disorder history
With 8 or more cycles within past 12 months
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, Week 6Population: The ITT population includes all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment in any efficacy variable
CDRS-R total score: changes from baseline over time - mixed model for repeated measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures. The CDRS-R total score ranges from 17-113. In general, higher values of CDRS-R total score represent greater severity of illness. The primary efficacy endpoint will be assessed between the placebo and treatment group.
Outcome measures
| Measure |
Luradisone
n=173 Participants
Luradisone 20- 80 mg administered once daily
Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily
|
Placebo
n=170 Participants
Placebo administered once daily
Placebo: Placebo Comparator once daily
|
|---|---|---|
|
Change in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score as Compared to Placebo From Double-Blind Baseline to Week 6 (Day 43) Baseline
baseline
|
59.2 units on a scale
Standard Deviation 8.24
|
58.6 units on a scale
Standard Deviation 8.26
|
|
Change in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score as Compared to Placebo From Double-Blind Baseline to Week 6 (Day 43) Baseline
week 6
|
-21.0 units on a scale
Standard Deviation 1.06
|
-15.3 units on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: baseline and week 6Population: The ITT population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment in any efficacy variable
PARS score: changes from baseline over time - mixed model for repeated measures-LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures.The PARS is a clinician-rated instrument for assessing over time the severity of anxiety symptoms associated with common DSM-IV anxiety disorders in children ages 6-17 years. The PARS is administered separately to the subject and to the caregiver. The instrument has 2 sections. The first section includes a 50-item symptom checklist, which the clinician rates as present or absent during the past week. The second section is comprised of 7 severity impairment items reflecting the severity/impairment of all symptoms endorsed in Section 1 of the PARS (during the past week). Each question is answered on a 0-5 Likert scale (0 for none, and 1-5 for minimal to extreme) with alternative responses of 8=Not Applicable and 9=Does Not Know. The PAR total score over all 7 questions ranges in value from 0 to 35.
Outcome measures
| Measure |
Luradisone
n=173 Participants
Luradisone 20- 80 mg administered once daily
Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily
|
Placebo
n=170 Participants
Placebo administered once daily
Placebo: Placebo Comparator once daily
|
|---|---|---|
|
Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Score as Compared to Placebo.
baseline
|
10.9 units on a scale
Standard Deviation 7.72
|
11.5 units on a scale
Standard Deviation 7.60
|
|
Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Score as Compared to Placebo.
week 6
|
-3.4 units on a scale
Standard Deviation 0.44
|
-2.3 units on a scale
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: baselinePopulation: the ITT population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment on any efficacy variable
PQ-LES-Q percentage maximum possible score: changes from baseline over time - mixed model for repeated measures LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures
Outcome measures
| Measure |
Luradisone
n=173 Participants
Luradisone 20- 80 mg administered once daily
Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily
|
Placebo
n=169 Participants
Placebo administered once daily
Placebo: Placebo Comparator once daily
|
|---|---|---|
|
Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Score as Compared to Placebo.
baseline
|
49.6 units on a scale
Standard Deviation 15.49
|
49.7 units on a scale
Standard Deviation 17.31
|
|
Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Score as Compared to Placebo.
week 6
|
11.8 units on a scale
Standard Deviation 1.10
|
7.9 units on a scale
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: baseline and week 6Population: the ITT population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment in any efficacy variable
CGAS Score: changes from baseline over time - mixed model for repeated measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures
Outcome measures
| Measure |
Luradisone
n=173 Participants
Luradisone 20- 80 mg administered once daily
Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily
|
Placebo
n=170 Participants
Placebo administered once daily
Placebo: Placebo Comparator once daily
|
|---|---|---|
|
Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score as Compared to Placebo.
baseline
|
48.8 units on a scale
Standard Deviation 8.73
|
49.5 units on a scale
Standard Deviation 6.99
|
|
Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score as Compared to Placebo.
week 6
|
14.0 units on a scale
Standard Deviation 0.96
|
9.3 units on a scale
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: baseline and week 6Population: The ITT population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment in any efficacy variable
ADHD-RS total score: changes from baseline over time -ANCOVA-LS Mean and SE for change from baseline are based on ANCOVA. The Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q is a 15-item self-report measure of the degree of enjoyment and satisfaction in various areas of daily living, based on the content of the Short From of the Q-LES-Q. Each item is rated on a 5-point scale, ranging from 1 (very poor) to 5 (very good). The first 14 items are the same as the General Activities section of the regular Q-LES-Q form and are used to compute the raw score. The PQ-LES-Q-SF percentage maximum possible score is calculated as follows:% Max = 100 × (Raw Score - Minimum Score) / (Maximum Score - Minimum Score),where the Minimum Score equals 14 and the Maximum Score equals 70, and the % maximum possible score can range from 0% to 100%. Higher scores indicate better quality of life.
Outcome measures
| Measure |
Luradisone
n=173 Participants
Luradisone 20- 80 mg administered once daily
Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily
|
Placebo
n=167 Participants
Placebo administered once daily
Placebo: Placebo Comparator once daily
|
|---|---|---|
|
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) Score as Compared to Placebo.
baseline
|
11.8 units on a scale
Standard Deviation 10.85
|
12.3 units on a scale
Standard Deviation 11.62
|
|
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) Score as Compared to Placebo.
week 6
|
-2.6 units on a scale
Standard Deviation 7.26
|
-2.0 units on a scale
Standard Deviation 7.61
|
SECONDARY outcome
Timeframe: baseline and week 6Population: the ITT population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment in any efficacy variable
Change from baseline in Clinical Global Impressions-Bipolar-Severity (CGI-BP-S) depression score changes from baseline over time - mixed model for repeated measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures.The CGI-BP-S is a three-question clinician-rated assessment of the subject's current illness state (depression, mania, and overall) using a 7-point scale (1(normal, not ill) to 7 (very severely ill)) for each question, where a higher score is associated with greater illness severity.
Outcome measures
| Measure |
Luradisone
n=173 Participants
Luradisone 20- 80 mg administered once daily
Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily
|
Placebo
n=170 Participants
Placebo administered once daily
Placebo: Placebo Comparator once daily
|
|---|---|---|
|
Change From Baseline in Clinical Global Impressions-Bipolar-Severity (CGI-BP-S) Depression Score
baseline
|
4.6 units on a scale
Standard Deviation 0.65
|
4.5 units on a scale
Standard Deviation 0.57
|
|
Change From Baseline in Clinical Global Impressions-Bipolar-Severity (CGI-BP-S) Depression Score
week 6
|
-1.49 units on a scale
Standard Deviation 0.085
|
-1.05 units on a scale
Standard Deviation 0.087
|
Adverse Events
Luradisone
Serious events: 2 serious events
Other events: 112 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Luradisone
n=175 participants at risk
Luradisone 20- 80 mg administered once daily
Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily
|
Placebo
n=172 participants at risk
Placebo administered once daily
Placebo: Placebo Comparator once daily
|
|---|---|---|
|
Psychiatric disorders
Bipolar I disorder
|
0.57%
1/175 • Number of events 1 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
0.58%
1/172 • Number of events 1 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
|
Psychiatric disorders
depression
|
0.00%
0/175 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
0.58%
1/172 • Number of events 1 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
|
Psychiatric disorders
psychotic disorder
|
0.00%
0/175 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
0.58%
1/172 • Number of events 1 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
|
Injury, poisoning and procedural complications
humerus fracture
|
0.57%
1/175 • Number of events 1 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
0.00%
0/172 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
|
Pregnancy, puerperium and perinatal conditions
abortion spontaneous
|
0.00%
0/175 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
0.58%
1/172 • Number of events 1 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
Other adverse events
| Measure |
Luradisone
n=175 participants at risk
Luradisone 20- 80 mg administered once daily
Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily
|
Placebo
n=172 participants at risk
Placebo administered once daily
Placebo: Placebo Comparator once daily
|
|---|---|---|
|
Nervous system disorders
headache
|
14.3%
25/175 • Number of events 30 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
15.1%
26/172 • Number of events 38 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
|
Nervous system disorders
somnolence
|
9.1%
16/175 • Number of events 20 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
4.7%
8/172 • Number of events 9 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
|
Nervous system disorders
dizziness
|
5.7%
10/175 • Number of events 12 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
4.7%
8/172 • Number of events 8 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
|
Gastrointestinal disorders
nausea
|
16.0%
28/175 • Number of events 35 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
5.8%
10/172 • Number of events 13 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
|
Gastrointestinal disorders
vomiting
|
6.3%
11/175 • Number of events 15 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
3.5%
6/172 • Number of events 8 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
|
Psychiatric disorders
insomnia
|
5.1%
9/175 • Number of events 9 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
2.3%
4/172 • Number of events 4 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
|
Infections and infestations
nasopharyngitis
|
4.0%
7/175 • Number of events 7 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
5.8%
10/172 • Number of events 10 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
|
Investigations
weight increased
|
6.9%
12/175 • Number of events 12 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
1.7%
3/172 • Number of events 3 • Through study completion. Treatment emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first does through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter the extension study or early discontinue during the double blind study), or through the last study day of the double blind period for subjects continuing into the extension study
number of participants at risk is equal to the number of patients in the safety population (172 in placebo and 175 in lurasidone)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER